On Thursday, the European Central Bank declared will start its 1 trillion euro ($1.1 trillion) bond-buying program on Monday, March 9, with expectations to end in September 2016, President Mario Draghi said during a press conference
Draghi also raised regional growth forecasts for 2015 and 2016 to 1.5 percent and 1.9 percent, respectively.
The Euro breached $1.09 after the jobs report on Friday.
Following U.S. stocks from healthcare sector seeking failure in the recent trade: Sunshine Heart Inc (NASDAQ:SSH), Geron Corporation (NASDAQ:GERN), Orexigen Therapeutics, Inc (NASDAQ:OREX), MannKind Corporation (NASDAQ:MNKD)
Their insights are depicted underneath:
Sunshine Heart Inc (NASDAQ:SSH)’s shares declined -26.36%, and is now trading at $3.94.
Sunshine Heart Inc. (SSH), declared an update on COUNTER HF(TM), the Corporation’s U.S. pivotal study which is a prospective, randomized, multi-center, controlled study evaluating the safety and efficacy of the C-Pulse system for the treatment of NYHA Class III and ambulatory Class IV heart failure.
The Corporation continues to experience raised interest from the medical and patient community regarding participation in the COUNTER HF study. In fact, over the past twelve months, the number of patients considering enrollment in this study has dramatically raised from 7 in Q1 2014 to approaching 100 for the first quarter in 2015.
While Sunshine Heart is happy with the study’s progress in terms of the recent enrollment pace and site interest, it will be taking a temporary pause from enrollment. This is in accordance with the study protocol where in the event more than three of the first twenty subjects pass away for any reason, counting non-device related deaths, the Corporation will work with the FDA to talk about a plan to resume enrollment. To date, of the four stated patient deaths, two have been adjudicated by an independent Clinical Events Committee (CEC) as being non-device related. The Corporation has received study documentation from the sites that stated the most recent two deaths that these were also non-device related. Patients already in the trial will continue follow-up according to the protocol.
The FDA has responded to Sunshine Heart’s notification and has advised the Corporation to file an IDE supplement that discusses the reasons for the temporary study suspension and a plan for study resumption. A supplement carries up to a 30-day review period by the FDA and the Corporation anticipates to submit the document by March 16, 2015.
Sunshine Heart will host its 2014 Q4 results conference call on March 17, 2015 following the submission of the COUNTER HF supplement document to the FDA. At this time, the Corporation’s administration team and Dr. Bill Abraham, one of the Study’s Principal Investigators, will be accessible to address questions as part of the standard quarterly conference call format.
Sunshine Heart, Inc. (SSH) is an early-stage medical device corporation focused on developing, manufacturing and commercializing the C-Pulse System for treatment of Class III and ambulatory Class IV heart failure. Sunshine Heart has accomplished an approved U.S. Food and Drug Administration (FDA) feasibility clinical study of the C-Pulse System and presented the results in November 2011.
Geron Corporation (NASDAQ:GERN), dipped -5.82%, and is now trading at $3.56.
Geron Corporation (GERN), stated financial results for the fourth quarter and year ended December 31, 2014 and recent events.
Year-End 2014 Results:
Net loss for 2014 was $35.7 million, or $0.23 per share, contrast to $38.4 million, or $0.30 per share, for 2013. License fee and royalty proceeds for 2014 and 2013 were $1.2 million and $1.3 million, respectively.
Total operating expenses for 2014 were $37.5 million contrast to $40.2 million for 2013. Research and development expenses for 2014 were $20.7 million contrast to $23.2 million for 2013. General and administrative expenses for 2014 were $16.8 million contrast to $15.6 million for 2013. Year-to-date operating expenses for 2013 also comprised of restructuring charges of $1.5 million.
The decrease in research and development expenses for 2014 contrast to 2013 primarily reflects the net result of lower clinical trial expenses with the wind-down of the imetelstat trials in solid tumors and GRN1005 trials in patients with brain metastases and reduced personnel-related and other research costs resulting from previous restructurings and the discontinuation of the corporation`s discovery research programs, partially offset by higher costs for the manufacturing of imetelstat drug product. The raise in general and administrative expenses for 2014 contrast to 2013 primarily reflects the net result of higher non-cash stock-based compensation expense, raised legal fees for the purported lawsuits filed against the corporation and transaction costs associated with the Partnership Contract with Janssen, partially offset by reduced patent fees and transaction costs associated with the closing of the stem cell divestiture transaction.
Interest and other revenue was $373,000 for 2014 contrast to $951,000 for 2013. The decrease in interest and other revenue for 2014 contrast to 2013 primarily reflects the net result of a gain on the sale of excess laboratory equipment in 2013, partially offset by higher interest revenue due to raised cash and investment balances in 2014.
Geron is a clinical stage biopharmaceutical corporation focused on the development of a first-in-class telomerase inhibitor, imetelstat, in hematologic myeloid malignancies.
Orexigen Therapeutics, Inc (NASDAQ:OREX) dropped -13.73%, and is now trading at $6.89.
Formerly on February 25, Orexigen Therapeutics, Inc. (OREX), declared business and financial results for the fourth quarter and year ended December 31, 2014.
Contrave (naltrexone HCl / bupropion HCl extended release):
Orexigen’s partner for North America, Takeda Pharmaceuticals, launched Contrave in the United States on October 20, 2014. U.S. net sales for the fourth quarter, recorded by Takeda, were $6.5 million, for which Orexigen earned $1.3 million in royalties. Gross sales for the quarter were $12.3 million.
Contrave is indicated as an adjunct to a reduced-calorie diet and raised physical activity for chronic weight administration in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (eg, hypertension, type 2 diabetes mellitus, or dyslipidemia).
Financial results for the three months ended December 31, 2014:
For the three months ended December 31, 2014, Orexigen stated a net profit of $0.6 million, or $0.00 per share, as contrast to a net loss of $21.5 million, or $0.21 per share, for the fourth quarter of 2013.
Total operating expenses for the fourth quarter of 2014 were $20.6 million contrast to $21.8 million for the fourth quarter of 2013.
Orexigen Therapeutics, Inc. is a biopharmaceutical corporation focused on the treatment of obesity. Orexigen developed Contrave® (naltrexone HCl and bupropion HCl extended release), which is approved in the United States and is being commercialized there by the corporation’s North American partner, Takeda Pharmaceuticals.
MannKind Corporation (NASDAQ:MNKD), dwindled -2.85%, and is now trading at $5.57.
Formerly on February 24, MannKind Corp. (MNKD), stated financial results for the fourth quarter and full year ended December 31, 2014.
For the fourth quarter, our operating expenses declined 35% contrast to the similar quarter in 2013. Research and development costs were significantly lower, mainly due to a reduction in non-cash compensation expenses and much lower clinical trial expenses following the completion of the Affinity studies in 2013. General and administrative costs declined 29%, mainly reflecting lower non-cash compensation expenses.
For the full year 2014, our total operating expenses raised modestly, with a decrease in research and development costs offset by an raise in general and administrative costs. Research and development costs reduced due to the completion of our Affinity trials, the pivotal clinical trials regarding the efficacy and safety of our novel inhaled insulin, Afrezza. Higher general and administrative costs resulted primarily from raised professional fees, principally related to the negotiation and completion of a partnership contract with Sanofi. In addition, professional fees reflected a noteworthy expansion in our program to identify, screen and fully evaluate new product opportunities that will best take advantage of the unique advantages of our Technosphere(R) drug delivery technology.
The net loss applicable to ordinary stockholders for 2014 was $198.4 million or $0.51 per share based on 385.2 million weighted average shares outstanding, slightly higher than the net loss to ordinary shareholders of $191.5 million, or $0.64 per share on 299.6 million weighted average shares outstanding in 2013. Our ordinary shares outstanding at year-end 2014 were 406.1 million.
MannKind Corporation (MNKD) focuses on the discovery and development of therapeutic products for patients with diseases such as diabetes.
